Specialist Engineering – Manufacturing Operations

About the role

The Specialist, Engineering joins the Technical Operations team supporting thaw, pool, and filling manufacturing areas. Reporting to the Associate Director, the role provides technical assistance, drives continuous improvement, and ensures compliance with GMP standards.

Key responsibilities

• Provide technical support for thawing/pooling/filling equipment, lead root‑cause investigations, and resolve equipment‑related quality events.
• Develop scientific justifications for process changes through literature review, experiment design, data analysis, and impact assessment on product quality and productivity.
• Support quality and regulatory activities, including site inspections, NDA supplement documentation, and FDA observations.
• Author and manage process change controls, ensuring accurate Process Descriptions and Critical Process Parameter Memos.
• Participate in on‑shift support during critical runs such as aseptic process simulations and developmental batches.

Required profile

• Bachelor’s degree in Engineering or related field.
• Minimum 2 years of experience in GMP pharmaceutical operations, technical services, or quality operations.
• Demonstrated leadership, teamwork, and strong oral and written communication skills.
• Mechanical aptitude for troubleshooting equipment issues.

Required skills

• Good Manufacturing Practices (GMP)
• Lean Six Sigma tools
• Change control management
• Equipment troubleshooting and design
• Process optimization and development
• Root‑cause analysis
• Technical writing and documentation
• Project management

What we offer

• Competitive salary range $87,300 – $137,400 per year.
• Annual bonus and long‑term incentive eligibility.
• Comprehensive benefits package including medical, dental, vision, 401(k), paid holidays, vacation, and sick days.